A state court in California has ruled that almost a dozen lawsuits against the pharmaceutical company Bayer can proceed. The lawsuits allege that Essure, a permanent birth control device manufactured by Bayer, can seriously injure patients.
Bayer Says Federal Regulations of Products Means They Are Not Liable for Injuries
Bayer wanted to have the Essure lawsuits dismissed on three grounds, for which a judge in Alameda County’s Superior Court ruled in favor of the plaintiffs. This was a huge blow against Bayer, as they could now still be liable for these lawsuits alleging harm, but the rulings also mean that more lawsuits are possible.
Bayer said that the plaintiffs were not allowed to file these lawsuits under federal preemption law. Bayer’s attorneys argued that since Essure had the approval of the United States Food and Drug Administration, Bayer should not be liable for any injuries. The court, however, disagreed. One attorney for some of the plaintiffs said, “It’s a court telling Bayer and other similar manufacturers that they don’t have immunity..."
Bayer Maintains That Essure Is Safe and Effective
Bayer claims that the permanent birth control device is safe and effective, according to the FDA. Per sales figures, about 900,000 women use Essure today. The device is made up of a nickel coil that is placed inside each fallopian tube. As the scar tissue surrounds the coils, it is supposed to block each tube and prevent eggs from entering the uterus or becoming fertilized. Part of the device’s appeal is that it can be inserted without any anesthesia or surgery.
There have been thousands of women, however, who have had problems with the birth control devices. Some of those problems include the device moving after it is inserted, organ perforation and severe pain. The FDA approved the device in 2002. Since then, over 5,000 adverse events have been reported on the FDA’s Manufacturer and User Facility Device Experience database. While the device hasn’t been recalled entirely, the FDA did recommend that a black box warning be issued.
Have You Been Injured Because of Essure?
Bayer has been accused of negligence, fraud and negligent misrepresentation in the California lawsuits. The plaintiffs claim that the pharmaceutical company failed because they didn’t monitor and test Essure, perform risk analysis regularly or exercise “reasonable care in its manufacturing and quality control process.” If you have been injured by Essure, an experienced lawyer can help you learn about your legal options.
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